RecruitingNCT05334927

China HeadAche DIsorders RegiStry


Sponsor

Beijing Tiantan Hospital

Enrollment

10,000 participants

Start Date

Aug 29, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

It is planned to include 10000 patients. In the China HeadAche DIsorders RegiStry CHAIRS), patients aged over 12 years with primary headache and medication-overuse headache(MOH) were collected. The biomarkers, imaging features, cognition, genetic characteristics, ocial and demographic data, medical data, therapeutics used, and outcome of headache-related diseases were studied, and long-term follow-up was planned.


Eligibility

Min Age: 12 Years

Inclusion Criteria4

  • Age ≥ 12 years old,Any gender;
  • The first onset age of primary headache was less than 50 years old(Age <65 years at first diagnosis of chronic migraine);
  • patients with primary headache (migraine, tension headache and other types of primary headache) or primary headache complicated with MOH according to ICHD-3;
  • Sign the informed consent form.

Exclusion Criteria7

  • According to the ICHD-3 diagnostic criteria, there are still headaches directly related to secondary factors (except drug overuse) at the time of enrollment;
  • Those who cannot be diagnosed as primary headache or primary headache combined with medication overuse headache according to ICHD-3;
  • According to DSM-V diagnostic criteria, patients with severe mental diseases (such as schizophrenia, mental disorders associated with mental retardation, etc.);
  • Patients with severe organic diseases, such as malignant tumors, and the expected survival time is less than 1 year;
  • Pregnant,planning pregnancy or Lactating women;
  • Subjects participating in other clinical trials;
  • Unable to cooperate to complete the follow-up due to geographical or other reasons

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALMedicine Overuse Headache/New Daily Persistent Headache

At the end of the 24th month visit, the patient is free to choose whether to conduct a face-to-face visit once a year until death.

BEHAVIORALEpisodic Migraine and Chronic Migraine

long-term follow-up

BEHAVIORALPatients with other types of primary headache

No collection Brain imaging、Cognitive function test、Biological sample

DRUGYangxue Qingnao Granules (Pills)

Participants who, in routine clinical practice, were prescribed Yangxue Qingnao Granules/Pills for acute headache relief and/or preventive management were enrolled. Treatment initiation, dosing, frequency, and duration were determined by the treating physician and the patient and were not assigned by the study protocol. During the 12-week observation period, participants were followed and outcomes were recorded, including relief of up to four headache episodes (for those using the medication for acute treatment) and longitudinal symptom measures at weeks 4, 8, and 12 (for those receiving preventive management).

BIOLOGICALErenumab

Participants who received eptinezumab for migraine prophylaxis in routine clinical practice were included. Treatment decisions (including whether to initiate eptinezumab, the selected dose \[e.g., 100 mg or 300 mg\], infusion interval, and duration) were made by the treating physician in consultation with the patient, and were not assigned by the study protocol. Patients were followed prospectively/retrospectively according to routine clinic visits, with outcome assessments captured at approximately 4-week intervals during the 12-week observation window (and additional follow-up when available).

BIOLOGICALEptinezumab

Participants who received eptinezumab for migraine prophylaxis in routine clinical practice were included. Treatment decisions (including whether to initiate eptinezumab, the selected dose \[e.g., 100 mg or 300 mg\], infusion interval, and duration) were made by the treating physician in consultation with the patient, and were not assigned by the study protocol. Patients were followed prospectively/retrospectively according to routine clinic visits, with outcome assessments captured at approximately 4-week intervals during the 12-week observation window (and additional follow-up when available).


Locations(20)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Beijing Chaoyang Hospital

Beijing, Beijing Municipality, China

Chongqing People's Hospital

Chongqing, Chongqing Municipality, China

Fujian Provincial Hospital

Fuzhou, Fujian, China

The First Affiliated Hospital of Guangxi University of Chinese Medicine

Nanning, Guangxi, China

The First People's Hospital of Zunyi

Zunyi, Guizhou, China

Ruijin-Hainan Hospital Shanghai Jiao Tong University School Of Medicine

Qionghai, Hainan, China

Zhangjiakou First Hospital

Zhangjiakou, Hebei, China

Luohe Central Hospital

Luohe, Henan, China

Luoyang Central Hospital

Luoyang, Henan, China

The Second Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

The 7th People's Hospital of Zhengzhou

Zhengzhou, Henan, China

Changzhou First People's Hospital

Changzhou, Jiangsu, China

Jiujiang First People's Hospital

Jiujiang, Jiangxi, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Huludao Central Hospital

Huludao, Liaoning, China

Zibo Municipal Hospital

Zibo, Shandong, China

Dachuan District People's Hospital

Dazhou, Sichuan, China

Deyang People's Hospital

Deyang, Sichuan, China

The First People's Hospital of Guangyuan

Guangyuan, Sichuan, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05334927


Related Trials